Communication and advertising of medical devices — Mastering the regulatory framework and securing your practices
Any public statement about a medical device — sales brochure, website, social media or field visit — falls within a precise and enforceable regulatory framework. MDR 2017/745, the French public health code, ANSM guidelines, the Charter of Quality of Professional Practices: requirements have been considerably strengthened since 2021. Marketing, regulatory affairs and sales must now work in concert to ensure the compliance of every message.
Audience Marketing managers and officers, regulatory affairs managers, sales directors and representatives, communication managers, in-house legal counsel in the medical device sector (manufacturers, distributors, importers, authorised representatives).
Learning objectives
- ▸ Identify the regulatory texts applicable to the communication and advertising of medical devices in France and in the European Union (MDR 2017/745, French public health code, ANSM guidelines, CEPS Charter 2022)
- ▸ Distinguish a promotional from a non-promotional material and apply the classification criteria to concrete cases from your own activity
- ▸ Analyse the compliance of a message or communication document with regard to the regulatory requirements in force
- ▸ Apply the specific rules for each communication channel (printed documentation, website, social media, field visits, congresses and professional events)
- ▸ Structure an internal procedure for validating promotional materials, integrating the roles of the marketing, RA and legal functions
- ▸ Assess the risks of non-compliance and the associated penalties in order to prioritise corrective actions
Expected outcomes
- ✓ A regulatory analysis grid that can be applied immediately to their existing materials
- ✓ A precise knowledge of the reporting obligations and required authorisations
- ✓ The ability to co-build with their teams a validation procedure compliant with the expectations of the ANSM and the CEPS
Accessibility & entry conditions
Access lead time
Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.
Prerequisites
No formal prerequisites. Initial exposure to the medical device sector (marketing, sales or regulatory function) is recommended to make the most of the case studies.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·This training is not Qualiopi-certified and is not fundable via the OPCOs
- ·Funding from own funds or the company's training budget
Detailed programme
A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.
- 01
Mapping of the applicable regulatory framework (1 h 30)
- ·Hierarchy of regulatory sources: MDR 2017/745, French public health code (articles L.5213-1 et seq.), consumer code, ANSM guidelines
- ·The Charter of Quality of Professional Practices (order of 8 March 2022, CEPS): scope, parties concerned, obligations and penalties (up to 10% of turnover on the products concerned)
- ·Articulation between European regulation and national law
- 02
Promotional versus non-promotional: definitions and classifications (1 h 30)
- ·Legal definition of an advertising material for medical devices
- ·Criteria for distinguishing between promotional communication, technical information and institutional communication
- ·Materials concerned: brochures, product sheets, sales presentations, e-mailings, websites, social media, congresses, webinars
- ·Case study: classification of representative sector materials
- 03
Rules applicable by communication channel (2 h)
- ·Printed and digital documentation: mandatory information, hierarchy of information, required validations
- ·Websites and digital platforms: identification of the site (institutional, promotional, e-commerce), terms of use, restricted access for healthcare professionals
- ·Professional and general-public social media: framing of publications, responsibility of field teams, third-party generated content
- ·Field visits: organisation, frequency, usable documents, access to healthcare establishments
- ·Professional events (congresses, symposia): rules on covering costs, traceability of documents handed out
- 04
Internal validation and control process (1 h)
- ·Roles and responsibilities: marketing, regulatory affairs, legal, management
- ·Validation circuit for a promotional material
- ·Documentation to be kept and retention period (5 years)
- ·Reporting obligations towards the ANSM
- ·Workshop: building a validation grid adapted to the organisation
- 05
Penalties, cases of non-compliance and feedback (1 h)
- ·Administrative and financial penalties incurred (CEPS, ANSM)
- ·Illustrations of cases of non-compliance in the sector (anonymised)
- ·Priority areas for bringing into compliance for organisations without a formalised validation process
- ·Questions / answers and summary of the knowledge acquired
Assessment of learning
Assessment methods
20-question QCM administered at the end of the session via the virtual classroom platform, covering all the modules. Collective commented correction at the close of the day.
Certificate
Training certificate issued by Isofac Group at the end of the training, subject to full participation in the session. This certificate does not constitute a certification recognised by the RNCP or the Specific Directory (RS).
Satisfaction and results
Satisfaction rate: Being measured
First learner survey campaign under way — data published once the statistical threshold is reached.
Training team
Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.
Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →
Technical resources
In-person
Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.
Remote
Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.
Learner equipment
A connected computer with camera and microphone for remote sessions. No software to install.
Materials provided
- ·Training slide deck in downloadable PDF format
- ·Summary sheet: table of applicable regulatory texts
- ·Promotional / non-promotional classification grid
- ·Internal validation circuit template
Post-course follow-up
Advice line
Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.
Follow-up review
3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.
Open-enrolment price (excl. VAT)
790 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·This training is not Qualiopi-certified and is not fundable via the OPCOs
- ·Funding from own funds or the company's training budget
Personalised quote within 48 hours.
Would you like to attend this course?
Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.